MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD LUBRI-SIL HYDROGEL COATED ALL SILICONE FOLEY CATHETER WITHOUT SYRINGE, MALE; LUBRISIL

Catalog Number 175812E

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during the pretest, the catheter formed a cuff.

Manufacturer Narrative

Received 4 unopened and 1 opened silicone catheters.The opened sample was evaluated and a cuff roll was noted on the sample returned.The unopened catheters did not show any defects.All samples received were functionally evaluated.The results were as follows: sample #1: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #2: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #3: the balloon was inflated with air and deflated by itself.A cuff roll was formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was formed.Sample #4: the balloon was inflated with air and deflated by itself.A cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was not formed.Sample #5: the balloon was inflated with air and deflated by itself.A cuff roll was formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe and the catheter was left for 3 minutes resting on a flat surface.It was then deflated by itself and a cuff roll was formed.Per the dimensional evaluation, the balloon active length of all samples were measured with a digital caliper.The results were as follows: sample #1: short side 0.5150¿ and on long side 0.5220¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #2: short side 0.5255¿ and on long side 0.5325¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #3: short side 0.5330¿ and on long side 0.5675¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #4: short side 0.5265¿ and on long side 0.5280¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.Sample #5: short side 0.5260¿ and on long side 0.5430¿ (specification is 0.5 - 0.8 in.).The balloon active length was found within specifications.The reported event was confirmed with an unknown cause on two of the samples received.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol" (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during the pretest, the catheter formed a cuff.

• Brand Name: BARD LUBRI-SIL HYDROGEL COATED ALL SILICONE FOLEY CATHETER WITHOUT SYRINGE, MALE
• Type of Device: LUBRISIL
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6338106
• MDR Text Key: 67949138
• Report Number: 1018233-2017-00512
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: 175812E
• Device Lot Number: NGZI4113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1